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Abstract

Background:

A new ELISA for autoantibodies to steroid 21-hydroxylase (21-OH Ab) is described.

Methods:

In the assay test sample autoantibodies form a bridge between 21-OH coated onto the plate well and liquid phase 21-OH-biotin. Bound 21-OH-biotin is detected by the addition of streptavidin peroxidase and colorogenic peroxidase substrate.

Results:

Of 100 samples from patients with autoimmune Addison’s disease, 86 (86%) were positive for 21-OH Ab ELISA whereas 84 (84%) were positive in an immunoprecipitation assay based on 125I-labeled 21-OH. Six (0.6%) of 928 healthy adult blood donors and 1 (2.0%) of 49 adult patients with type 1 diabetes mellitus (T1DM) were positive by ELISA. No samples from adult patients with Graves’ disease (GD; n=50), celiac disease (n=29), systemic lupus erythematosis (n=9) or rheumatoid arthritis (n=20) were positive by ELISA. However, 2/51 (3.9%) children with GD, 3/69 (4.3%) children with Hashimoto’s thyroiditis (HT) and 3/119 (2.5%) children with T1DM alone or associated with autoimmune thyroid disorders were ELISA positive.

Conclusions:

The new assay should be useful for screening patients known to be at increased risk of developing clinical autoimmune Addison’s disease, in particular children with HT, GD and/or T1DM.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: The work was funded by RSR Limited, Cardiff, UK.

Employment or leadership: MdPL, SC, NS, HM, LG, JF and BRS are employees of RSR Limited. RSR Ltd. is a developer of medical diagnostics, including kits for measuring 21-OH antibodies.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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